Evaluation of Efficacy and Safety of SDN-037

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 3

Conditions: Inflammation and Pain Associated With Ocular Surgery

Treatments: Drug: SDN-037; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03426267

CLR_16_31

Details and patient eligibility

About

The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be at least 2 years of age on the date of assent or 18 years of age at the date of consent
2. Be able and willing to follow study instructions and complete all required visits
3. Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test
4. Able to self-instill the IP or have a caregiver available to instil all doses of the IP

Exclusion criteria

1. Any known allergy or hypersensitivity to difluprednate therapy
2. An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
3. Any active corneal pathology noted in the study eye
4. Currently suffering from alcohol and/or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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325 participants in 2 patient groups, including a placebo group

SDN-037

Experimental group

Treatment:

Drug: SDN-037

vehicle

Placebo Comparator group

Treatment:

Drug: Placebo